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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 204635

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NDA 204635 describes MOXIFLOXACIN HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Lupin Ltd, Mankind Pharma, Pharmobedient, Regcon Holdings, Somerset Theraps Llc, Upsher Smith Labs, Fresenius Kabi Usa, Aurobindo Pharma Ltd, Chartwell Rx, Crossmedika Sa, Dr Reddys, Hetero Labs Ltd V, MSN, Natco, Sunshine, Teva Pharms Usa, Torrent, and Mylan Labs Ltd, and is included in twenty-five NDAs. It is available from thirty-one suppliers. Additional details are available on the MOXIFLOXACIN HYDROCHLORIDE profile page.

The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for 204635

Tradename:	MOXIFLOXACIN HYDROCHLORIDE
Applicant:	Natco
Ingredient:	moxifloxacin hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Aug 31, 2015	TE:		RLD:	No

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